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rapport d’alerte

English translation: incident report/alert or warning statement


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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:rapport d’alerte
English translation:incident report/alert or warning statement
Entered by: jeantrans
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08:27 Dec 26, 2011
French to English translations [PRO]
Medical - Medical: Pharmaceuticals
French term or phrase: rapport d’alerte
Que fait XXX afin de garantir la qualité et la sécurité de ses produits ?

Selon le rapport d’alerte de YYY adressé à la FDA le 14 novembre 2011, et aux réponses apportées à l'EMA(demande du 23 novembre 2011), il n’y a actuellement aucun élément permettant de remettre en cause la sécurité ou l’efficacité des produits de XXX suite aux constats fait lors de l’inspection de l'EMA.
XXX a développé un plan d’action afin de transférer la fabrication du diluant sur un site de production différent. Les seuls stocks disponibles à ce jour sont les stocks provenant de YYY (les derniers ayant été fabriqués en août 2010).
XXX continue de surveiller les remontées de PV ainsi que les réclamations qualité afin de s’assurer qu’il n’y ait pas de soucis de qualité/sécurité des lots actuellement disponibles dans les différents marchés.

I get the meaning of this, but just not sure how to express it in English.

warning report?
alert report?
safety alert?
jeantrans
incident report
Explanation:
that's what we hear in the States, where we tend to avoid alarming words. I leasrned thard way that you don't use the word "problème" to translate the English "issue" . I did once during an interpreting session and the English side jumped ot of their chairs. "Problems, what problems. There are no problems!" An issue you address, a problem just messes your mojo.
Selected response from:

jmleger
Local time: 11:19
Grading comment
I'm putting both answers in the glossary, but as you know I can only award points to one of them. I think either could work depending upon the context. Thanks to everyone.
4 KudoZ points were awarded for this answer



Summary of answers provided
4incident report
jmleger
4alert or warning statement
Drmanu49


Discussion entries: 1





  

Answers


8 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
alert or warning statement


Explanation:
law.justia.com/cfr/.../21-5.0.1.1.30.html - États-Unis - Traduire cette page
369.4 Warnings suggested for drugs by formal or informal statements of policy. ... 369.21 Drugs; warning and caution statements required by regulations. ...

www.fda.gov/Drugs/Drugsafety/ucm270296.htm - Traduire cette page
FDA, U.S. Food and Drug Administration. U.S. Food & Drug Administration ... Drug Alerts and Statements · Importing Prescription Drugs · Medication Guides ...

Drmanu49
Local time: 18:19
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 653
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
incident report


Explanation:
that's what we hear in the States, where we tend to avoid alarming words. I leasrned thard way that you don't use the word "problème" to translate the English "issue" . I did once during an interpreting session and the English side jumped ot of their chairs. "Problems, what problems. There are no problems!" An issue you address, a problem just messes your mojo.

jmleger
Local time: 11:19
Native speaker of: Native in FrenchFrench
PRO pts in category: 8
Grading comment
I'm putting both answers in the glossary, but as you know I can only award points to one of them. I think either could work depending upon the context. Thanks to everyone.
Login to enter a peer comment (or grade)




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